MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumours

Official Title

A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability,Pharmacokinetics, Biological and Clinical Activity of MSB0011359C in Subjects With Metastatic or Locally Advanced Solid Tumours and Expansion to Selected Indications

Summary:

The main purpose of this Phase I study is to test MSB0011359C (M7824) at different dose levels to see if it is safe and well tolerated when given once every 2 weeks. Phase I means the study drug has not previously been given to humans or has only been given to a limited number of people, although it has been extensively studied in animals. Based on this information, it is hoped to find out which dose could be best for the treatment of patients. There are two parts of this research study: a dose-escalation part and an expansion part. Dose escalation means that the first people taking part in the study will receive low doses of the study drug, and as more people take part, the additional participants will receive a higher dose. This is done to find the safest dose for the study drug. Expansion means that after the dose-escalation part of the study has looked at the safety and effectiveness of different doses, many more people will be invited to take part in the study and will receive the study drug at the safest dose. Additional purposes of the study are to find out whether the study drug has anti-cancer effects and how the study drug is processed by the body.

Trial Description

Primary Outcome:

  • Dose-escalation Part: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
  • Dose-escalation Part: Number of Subjects With Treatment-Related AEs
  • Dose-escalation Part: Number of Treatment Emergent Adverse Events (TEAEs) and Related TEAEs by Severity
  • Dose-escalation Part: Duration of Treatment Emergent Adverse Events (TEAEs) and Related TEAEs
  • Dose-escalation Part: Number of Subjects With Dose Limiting Toxicities (DLT)
  • Dose-expansion Part: Best Overall Response (BOR) as Assessed by Independent Endpoint Review Committee (IRC)
  • Dose-expansion Part: Disease Control Rate According to Response Assessment in Neuro-Oncology (RANO) as Adjudicated by the IRC for Subjects With Glioblastoma
Secondary Outcome:
  • Dose Escalation and Expansion Part: Maximum Concentration (Cmax) of MSB0011359C in Plasma
  • Dose Escalation and Expansion Part: Minimum Concentration (Cmin) of MSB0011359C in Plasma
  • Dose Escalation and Expansion Part: Area Under the Plasma Concentration Time Curve From Zero to Last Sampling Time (AUC0-t) of MSB0011359C
  • Dose Escalation and Expansion Part: Terminal Half Life (t1/2) of MSB0011359C
  • Dose Escalation and Expansion Part: Serum Titers of Anti-MSB0011359C Antibodies
  • Dose Escalation and Expansion Part: Best Overall Response (BOR) as Assessed by Investigator
  • Dose Expansion Part: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
  • Dose Expansion Part: Number of Subjects With Treatment-Related AEs
  • Dose Expansion Part: Number of Treatment Emergent Adverse Events (TEAEs) and Related TEAEs by Severity
  • Dose Expansion Part: Duration of Treatment Emergent Adverse Events (TEAEs) and Related TEAEs
This is a Phase I, open-label, dose-escalation trial with consecutive parallel-group expansion in selected solid tumour indications. The current trial is composed of a standard dose escalation "3 + 3" cohort design, for which 3 to 6 subjects will be enrolled at each dose level depending on the occurrence of dose limiting toxicities (DLTs), followed by a consecutive parallel-group expansion in selected solid tumour indications. Cohorts of 3 subjects with metastatic or locally advanced solid tumours, for which no standard effective therapy exists or standard therapy has failed, will receive MSB0011359C (M7824) at escalating dose levels. After determination of the Maximum tolerated dose (MTD), enrollment in several expansion cohorts will be opened to determine the safety, pharmacokinetic (PK) / Pharmacodynamic, and clinical activity of MSB0011359C (M7824). Subjects who have experienced a confirmed complete response (CR) should continue treatment through the end of 12 months, although additional treatment is possible. In the case of progressive disease (PD), subjects should continue treatment through their next tumour assessment. Additional indications will be planned based on emerging data in the field.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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